Selincro 18 mg

Parenteral

Opioid overdosage

Adult: IV route preferred; may administer via IM or SC should IV access be lost or not readily attainable. Non-opioid dependent patients: Initial: 0.5 mg/70 kg; followed by a 2nd dose of 1 mg/70 kg after 2-5 min if needed. If no clinical response observed after total dose of 1.5 mg/kg, additional doses are unlikely to provide therapeutic effect. Opioid-dependent patients: Initial: A challenge dose of 0.1 mg/70 kg; if no withdrawal symptoms are observed in 2 min, may be followed by the incremental dosing recommended.

Incompatibility: Compatible with 0.9% sodium chloride inj.

Parenteral

Reversal of central depression from opioid use during surgery

Adult: Titrate dose to reverse undesired effects of opioids without inducing a complete reversal and acute pain. Initial: 0.25 mcg/kg administered via IV/IM/SC route; followed by 0.25 mcg/kg incremental doses at 2-5 min intervals until desired opioid reversal is achieved. Cumulative total dose above 1 mcg/kg does not provide additional therapeutic effect. Patients with increased CV risks: Dilute Selincro 18 mg with normal saline or sterile water for inj to 1:1 ratio; initiate and titrate at 0.1 mcg/kg every 2-5 min intervals.

Renal impairment: Administer incremental doses slowly (over 60 seconds) to minimise HTN and dizziness.

Incompatibility: Compatible with 0.9% sodium chloride inj.

Completely or partially reversing the effects of narcotics and managing known or suspected overdose of narcotics. It may also be used for other conditions as determined by your doctor.

Selincro 18 mg is a narcotic antagonist. It works by blocking opiate receptor sites, which reverses or prevents toxic effects of narcotic (opioid) analgesics.

Applies to the following strengths: 1 mg/mL; 100 mcg/mL

Usual Adult Dose for:

• Reversal of Opioid Sedation
• Opioid Overdose

Additional dosage information:

• Renal Dose Adjustments
• Liver Dose Adjustments
• Dose Adjustments
• Precautions
• Dialysis

Usual Adult Dose for Reversal of Opioid Sedation

Initial dose: 0.25 mcg/kg intravenously once as an initial dose, followed by 0.25 mcg/kg incremental doses at 2 to 5 minute intervals until the desired degree of opioid reversal is obtained.

If no response after cumulative dose of 1 mcg/kg administered, additional doses are unlikely to provide an effect.

Usual Adult Dose for Opioid Overdose

Initial dose: 0.5 mg/70 kg IV one time. May follow with 1 mg/70 kg IV administered 2 to 5 minutes after initial dose. If no response after 1.5 mg/70 kg administered, additional doses are unlikely to provide an effect.

If there is reasonable suspicion of opioid dependency, an initial challenge dose of 0.1 mg/70 kg IV should be administered. If, after 2 minutes, there is no withdrawal response the recommended dosing should be followed.

If IV access is unavailable, administer 1 mg subcutaneously or intramuscularly.

Renal Dose Adjustments

The clearance of Selincro 18 mg is significantly reduced (27%) in renal dysfunction. A dosage adjustment is not necessary for the treatment of a single episode of opioid antagonism. However, incremental doses should be delivered slowly (over 1 minute) in cases of severe renal dysfunction. Rapid administration, in this patient population, may increase the incidence of hypertension and dizziness.

Liver Dose Adjustments

Although the pharmacokinetic disposition is altered in patients with hepatic dysfunction, no dosage adjustments are necessary since Selincro 18 mg is administered as an acute course of therapy.

Dose Adjustments

If necessary, the dose may be administered IM or subcutaneously. The onset of action with IM or subcutaneous administration should occur within 5 to 15 minutes.

Precautions

Selincro 18 mg, like all drugs in this class, is not the primary therapy for ventilatory failure. In most emergency settings, therapy with Selincro 18 mg should follow, not precede, the establishment of a patent airway, ventilatory assistance, administration of oxygen, and establishment of circulatory access.

Accidental overdose with long acting opioids (such as methadone and levo-alpha-acetylmethadol) may result in prolonged respiratory depression. Respiratory depression in both the postoperative and overdose setting may be complex and involve the effects of anesthetic agents, neuromuscular blockers, and other therapies. While Selincro 18 mg has a longer duration of action than naloxone in fully reversing doses, the prescriber should be aware that a recurrence of respiratory depression is possible, even after an apparently adequate initial response to Selincro 18 mg treatment. Patients treated with Selincro 18 mg should be observed until, in the opinion of the prescriber, there is no reasonable risk of recurrent respiratory depression.

Caution should be used when administering Selincro 18 mg to patients at risk of cardiovascular complication or in patients who have received cardiotoxic medications. Opioid reversal has been associated with pulmonary edema, cardiovascular instability, hypotension, hypertension, ventricular tachycardia, ventricular fibrillation, and excessive mortality in patients at high risk for cardiovascular complications.

Selincro 18 mg administration may precipitate acute and prolonged withdrawal symptoms in opioid dependent patients or following surgery involving high doses of opioids.

Selincro 18 mg therapy may not completely reverse buprenorphine-induced respiratory depression.

The safety and efficacy of Selincro 18 mg in pediatric patients has not been determined.

Dialysis

The clearance of Selincro 18 mg is significantly reduced (27%) in renal dysfunction. A dosage adjustment is not necessary for the treatment of a single episode of opioid antagonism. However, incremental doses should be delivered slowly (over 1 minute) in cases of severe renal dysfunction. Rapid administration, in this patient population, may increase the incidence of hypertension and dizziness.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

More about Selincro 18 mg

• Selincro 18 mg Side Effects
• During Pregnancy
• Drug Interactions
• Drug class: antidotes

Professional resources

• Selincro 18 mg Hydrochloride (AHFS Monograph)

Related treatment guides

• Opioid Overdose
• Reversal of Opioid Sedation

See also:
What is the most important information I should know about Selincro 18 mg?

Selincro 18 mg is contraindicated in patients with a known hypersensitivity to the product.

Use Selincro 18 mg as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Selincro 18 mg is usually administered as an injection at a hospital or clinic.
• If Selincro 18 mg contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it.
• Keep this product, as well as syringes and needles, out of the reach of children. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor or pharmacist to explain local regulations for proper disposal.
• If you miss a dose of Selincro 18 mg, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Selincro 18 mg.

See also:
What other drugs will affect Selincro 18 mg?

nalmemfene has been administered after benzodiazepines, inhalational anesthetics, muscle relaxants, and muscle relaxant antagonists administered in conjunction with general anesthesia. It also has been administered in outpatient settings, both in trials in conscious sedation and in the emergency management of overdose following a wide variety of agents. No deleterious interactions have been observed.

Preclinical studies have shown that both flumazenil and Selincro 18 mg can induce seizures in animals. The coadministration of both flumazenil and Selincro 18 mg produced fewer seizures than expected in a study in rodents, based on the expected effects of each drug alone. Based on these data, an adverse interaction from the coadministration of the two drugs is not expected, but physicians should remain aware of the potential risk of seizures from agents in these classes.

Carcinogenesis and Mutagenesis and Impairment of Fertility

Selincro 18 mg did not have mutagenic activity in the Ames test with five bacterial strains or the mouse lymphoma assay. Clastogenic activity was not observed in the mouse micronucleus test or in the cytogenic bone marrow assay in rats. However, Selincro 18 mg did exhibit a weak but significant clastogenic activity in the human lymphocyte metaphase assay in the absence but not in the presence of exogenous metabolic activation.

Oral administration of Selincro 18 mg up to 1200 mg/m 2/day did not affect fertility, reproductive performance, and offspring survival in rats.

See also:
What are the possible side effects of Selincro 18 mg?

Applies to Selincro 18 mg: parenteral injection

Side effects include:

Nausea, vomiting, tachycardia, hypertension.